SIENTRA Silicone Gel Breast Implant Sizer GS10621-650MP

GUDID 00819409024018

Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 650 cc

Sientra, Inc.

Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use Invasive breast implant sizer, fixed, single-use
Primary Device ID00819409024018
NIH Device Record Key1414e486-4b78-4ad3-9090-bf552f52c20c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSIENTRA Silicone Gel Breast Implant Sizer
Version Model NumberGS10621-650MP
Catalog NumberGS10621-650MP
Company DUNS010209877
Company NameSientra, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com
Phone888-708-0808
Emailcustomer.experience@sientra.com

Device Dimensions

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Device Identifiers

Device Issuing AgencyDevice ID
GS100819409024018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MRDSizer, Mammary, Breast Implant Volume

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-10
Device Publish Date2021-08-02

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00819409024179Silicone Gel Breast Implant Sizer, Smooth Round, Xtra High Projection, 470 cc
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00819409024117Silicone Gel Breast Implant Sizer, Smooth Round, Xtra High Projection, 315 cc
00819409024100Silicone Gel Breast Implant Sizer, Smooth Round, Xtra High Projection, 295 cc
00819409024094Silicone Gel Breast Implant Sizer, Smooth Round, Xtra High Projection, 275 cc
00819409024025Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 695 cc
00819409024018Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 650 cc
00819409024001Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 625 cc
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00819409023974Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 540 cc
00819409023967Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 525 cc
00819409023943Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 485 cc
00819409023936Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 455 cc
00819409023912Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 415 cc
00819409023899Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 355 cc
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00819409023875Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 305 cc
00819409023851Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 255 cc
00819409023844Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 235 cc
00819409023837Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 215 cc
00819409023820Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 195 cc
00819409023813Silicone Gel Breast Implant Sizer, Smooth Round, Moderate Plus Projection, 175 cc
00819409023738Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 700 cc
00819409023721Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 650 cc
00819409023714Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 620 cc
00819409023707Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 590 cc
00819409023691Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 565 cc
00819409023677Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 505 cc
00819409023660Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 470 cc
00819409023653Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 440 cc
00819409023622Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 350 cc
00819409023578Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 240 cc
00819409023561Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 225 cc
00819409023547Silicone Gel Breast Implant Sizer, Smooth Round, High Projection, 190 cc
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00810076891811Silicone Gel Breast Implant Sizer, Smooth Round, Low Plus Projection, 320 cc
00810076891804Silicone Gel Breast Implant Sizer, Smooth Round, Low Plus Projection, 300 cc
00810076891798Silicone Gel Breast Implant Sizer, Smooth Round, Low Plus Projection, 280 cc
00810076891781Silicone Gel Breast Implant Sizer, Smooth Round, Low Plus Projection, 255 cc
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